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510(k) K101855

PROFAST+ ASSAY by Gen-Probe Prodesse, Inc. — Product Code OQW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2010
Date Received
July 1, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Device Class
Class II
Regulation Number
866.3332
Review Panel
MI
Submission Type

2009 H1N1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 H1N1 influenza virus in human respiratory specimens

Other clearances by Gen-Probe Prodesse, Inc.

  • K132238 — PROPARAFLU+ ASSAY (August 26, 2013)
  • K132237 — PRODESSE PROFAST+ ASSAY (August 26, 2013)
  • K132159 — PROADENO+ ASSAY (August 14, 2013)
  • K132200 — PRO HMPV+ ASSAY (August 14, 2013)
  • K132129 — PRODESSE PROFLU+ ASSAY (August 9, 2013)
  • K123838 — PRO HMPV+ ASSAY (January 16, 2013)
  • K123274 — PROGASTRO SSCS ASSAY (January 16, 2013)
  • K110968 — PROFLU+ ASSAY (June 27, 2011)
  • K102952 — PRODESSE PROADENO (December 3, 2010)

Other clearances for product code OQW

  • K132237 — PRODESSE PROFAST+ ASSAY (August 26, 2013)
  • K130551 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (May 22, 2013)
  • K123905 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (January 14, 2013)
  • K120911 — XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) (May 18, 2012)
  • K111778 — JBAIDS INFLUENZA A SUBTYPING KIT (September 13, 2011)
  • K111507 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (August 23, 2011)
  • K103766 — XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOF (April 21, 2011)
  • K101564 — CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL (June 22, 2010)
  • K100148 — SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 (May 24, 2010)